Multi-Piece Punctal Plug

ABSTRACT

A multi-piece punctal plug has one a superficial plug removably connected to an anchor plug deeper in the naso-lacrimal canaliculus. The anchor is fixed to the wall of the lacrimal duct while the superficial plug is axially and detachably secured to the anchor plug so that the multi-plug complex may be inserted or removed together as one, or the superficial plug may be detached separately and replaced securely without disturbing the anchor. Removal and insertion is accomplished by a specific tool having an end for reversibly engaging the plugs.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 12/326,622filed Dec. 2, 2008, which application is incorporated herein byreference and is now U.S. Pat. No. 8,______ issued ______.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates generally to the field of ophthalmology,and in particular to a new and useful punctal plug that is made up ofmultiple parts to enhance its effectiveness.

US Patent Application 2005/0232972 to the same inventor as the presentapplication, is incorporated here by reference, and discloses a methodand an apparatus for administering an active agent to a subject byapplying the active agent to at least one surface of an ocular implantsuch as a punctal plug, and installing the implant, e.g. inserting thepunctal plug into a punctal aperture of the subject.

Although the use of punctal plugs to deliver a drug to the eye, or tothe body, or for other purposes, is known, retention of the plugs overtime continues to be problematic since the plugs tend to fall outprematurely.

SUMMARY OF THE INVENTION

It is accordingly an object of the present invention to overcome theretention problem of current punctal plug delivery designs by providinga multi-piece punctal plug for any appropriate function, that has ananchoring component which is designed to be securely anchored in thelacrimal duct near the punctum, to receive a superficial plug componentthat, in turn, can be attached securely and detached at thepractitioner's discretion, in a controlled fashion.

This may be accomplished, according to the invention, and for example,by threading the superficial plug component to the anchoring componentfor a “screw in” and “unscrew” technique, or a mechanical spring loadedlatching structure and process may be used, or a bayonet connection, orother reversible and controllable attachment mechanism and method thatis currently known or that is here after discovered, may be used.

The invention is directed to the punctal plug in general and may beembodied, for example as follows.

1. A punctal plug of multi-piece design, specifically with an anchoringpiece which sits deep within the canaliculus and is firmly attached tothe walls using any method, e.g. a mechanical method with an expansileelement to wedge the anchoring plug permanently in position, springloaded prongs which emerge from the anchoring plug and fix it inposition reversibly, or a chemical method which bonds it in place.

2. A punctal plug of multi-piece design with a superficial part which isdesigned to attach, reversibly, to the deeper anchoring plug. Twopossible but not limiting embodiments are using a screw-in method or aspring-loaded latching method as noted above, both enabling the removalof the superficial plug at the practitioner's discretion, while leavingthe anchoring plug in place deeper in the canal.

3. A punctal plug of multi-piece design in which the anchoring plug isdesigned to receive the superficial plug or plugs. This might include ascrew in opening or a shape to receive a spring-loaded latch.

4. A punctal plug of multi-piece design wherein either or all parts areimparted with medicine to deliver to the eye or the systemiccirculation.

5. A punctal plug of multi-piece design in which all pieces arepossessed of a radio-opaque element which allows for identification onX-ray/imaging procedures.

The invention includes the method for unscrewing or other wisedisconnecting the superficial plug component from the anchoring plug oranchor component, as this has not been described previously.

Accordingly, a further object of the invention is to provide a punctalplug that comprises an anchor for being received in a lacrimal duct anda plug for extending into the anchor, the anchor being fixed to the wallof the lacrimal duct and the plug being axially and detachably securedto the anchor so that with the plug connected to the anchor, the plugand anchor can be inserted into, and removed from the lacrimal ductusing a tool having an end for engaging the plug.

The various features of novelty which characterize the invention arepointed out with particularity in the claims annexed to and forming apart of this disclosure. For a better understanding of the invention,its operating advantages and specific objects attained by its uses,reference is made to the accompanying drawings and descriptive matter inwhich a preferred embodiment of the invention is illustrated.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a partial and schematic view of the eye and nose area of apatient who would benefit from the punctal plug arrangement of thepresent invention;

FIG. 2 is an enlarged exploded view that is partly in section, of anembodiment of the invention;

FIG. 3 is a view of the embodiment of FIG. 2 in the lacrimal duct of apatient;

FIG. 4 is a view similar to FIG. 2 but of a further embodiment of theinvention; and

FIG. 5 is a view similar to FIG. 2 but of a still further embodiment ofthe invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, in which like reference numerals are usedto refer to the same or similar elements, FIG. 1 shows the eye and nosearea of a patient who would benefit from the punctal plug arrangement ofthe present invention. To better understand the environment in which theinvention will operate, the patient is shown to have an eye 10 abovewhich are located lacrimal glands 12 for producing tears. The tears willwet and coat the eye and will eventually move to the upper and lower lidmargins 14 and then be channeled to the upper and lower punctum 16. Thetears will then travel along the upper and lower canaliculus 18 andlacrimal ducts 20 (collectively referred to here simply as the lacrimalducts), into the nasolacrimal duct 22 and then to the nasal cavity 24.

Referring now to FIGS. 2 and 3, a punctal plug arrangement 30 of thepresent invention is received in one of the lacrimal ducts 18, 20, at ornear the corresponding lacrimal punctum 16 of a patient. Since thepatient has four such lacrimal ducts, up to four punctal plugs of thepresent invention can be used, each for a known mechanical purpose suchas blocking the passage of tears or, with a passage through the plug,enhancing the passage of tears, or for a known medicating purpose suchas supplying a medicament that is incorporated in the plug to thepatient. According to the present invention, since each plug actuallyhas two, or even more parts in some embodiments, and each can be loaded,using known technology, with a different medication, many more than fourdifferent medicaments can be supplied to one patient at the same time.

Each punctal plug arrangement 30 of the invention includes at least oneanchor 32, and one plug 34. The anchor 32 and plug 34 are eachadvantageously made of any bio-compatible material such as plastic, likesilicone, or metal, like titanium, or metal impregnated plastic. It isalso advantageous for either the anchor or the plug or both to be madeof radio-opaque material or to be coated to be radio-opaque, so that theanchor and/or the plug are visible in an X-ray image.

Referring now to FIG. 2 in particular, the punctal plug arrangement 30for placement in a lacrimal duct 20 of a patient, comprises the anchor32 having an inner plug engaging recess 36 and an outer surface forengaging a wall of a lacrimal duct 20 for receiving the anchor. The plug34 has a stem 38 for extending into the plug engaging recess 36 of theanchor 32. The plug 34 also has a head 40 connected to the stem 38, thehead having a larger diameter then the stem for engaging around thelacrimal punctum 16 at an end of a lacrimal duct 18, 20, in which theanchor is received. The head 40 includes a tool engaging recess 42 forreceiving the end 52 of a tool 50 for placing and for removing the plugand anchor, to be described later in this disclosure.

The anchor may have a radial skirt 44 to increase its fixation to theduct 20, and, according to the invention, anchor fixing means 46 at theouter surface of the anchor 32, such as a plurality of fixed or movableprojections, provided for further fixing the anchor 32 to the wall of alacrimal duct. The arrangement also includes plug fixing means such as amale thread on the stem 38 for treading into a female thread in the plugengaging recess 36, for detachable and axially securely connecting theplug 34 to the anchor 32, so that with the plug connected to the anchor,the plug and anchor can be inserted as a unit into, and removed as aunit from the lacrimal duct 20.

The arrangement of the invention includes the tool 50 having the end 52for engaging the tool engaging recess 42 of the plug 34, the end of thetool and the tool engaging recess being shaped for axial securement ofthe tool to the plug so that the tool can be used to positively hold theplug, to facilitate insertion and removal of the plug and connectedanchor into and out from the lacrimal duct.

In the embodiment of FIG. 2, this axial securement is achieved by makingthe tool engaging recess 42 of plug 34 larger at its base than at itsentry end, and the end 52 of the tool to be radially expandable. Thus,with the tool end 52 in the tool engaging recess 42, end 52 is expandedin the larger base of the tool engaging recess 42 so that the tool isaxially fixed to the plug. With the plug 34 also axially fixed to theanchor 32, e.g. by the threads, the plug plus the anchor, as a unit, canbe securely held by the practitioner and inserted into the lacrimal ductthrough to punctum 16.

The radial expansion of tool end 52 can be provided by cutting aplurality of slots in the tool end 52 to form a plurality of prongs atthe tool end, and by providing a central axial bore through the lengthof the tool 50. The bore has a constant diameter at the top of the tool,and becomes slightly smaller or tapers inwardly at 58, in the area ofthe tool end 52 and its slots and prongs. A cylindrical plunger 54 isslidably mounted into this cylindrical bore and has a top button end 56that can be pressed by the practitioner. The lower end 60 of the plunger54 stops just above the taper 58 in an initial condition of the tool 50,so that the prongs defined by the slots at the tool end 52, lay in thesame plane as the six faces of the hexagonal tool body of tool 50. Inthis initial condition the tool end 52 can be inserted into the toolengaging recess 42 which is also hexagonal so that rotation of the tool50 can be used to screw the plug stem into the anchor.

To axially secure the tool 50 to the plug 34, button 56 is presseddownwardly with respect to the tool body so that the plunger end 60 willslide along the inside tapered surfaces 58, and thereby cause the prongsto move radially outwardly into the enlarged base of tool receivingrecess 42. In this engaged condition the plug plus anchor unit can besecurely held and manipulated by the practitioner using the tool. Theprongs are maintained in the expanded state due to friction between theplunger end 60 and the surfaces 58. Once the multi-part punctal plug 30of the invention is in place, the practitioner will manually pull theplunger partly back out of the tool body to allow the prongs to springback to their initial condition so that the tool end 52 can be releasedfrom the recess 42 and the plug 34.

The same procedure can be used to engage and extract the plugarrangement of the invention from the lacrimal duct.

Referring now to FIG. 4, the multi-part punctal plug arrangement of theinvention comprises an anchor 32, plug 34 and tool 50, but has plugfixing means for connecting the plug to the anchor that comprises atleast one, but preferably two, three or four radially movable latches 66on the plug stem 38, and a latch seat 68 in the plug engaging recess 36of the anchor, for detachably and axially securing the plug to theanchor.

The tool 50 includes latch retracting means for retracting the latch 66,radially inwardly to disengage the latch 66 from the latch seat 68 anddisconnect the plug from the anchor. The anchor fixing means comprises aplurality of movable projections 47 on the outer surface of the anchorfor engaging the wall of a lacrimal duct, the projections being radiallymovable and the tool including means for radially retracting theprojections for facilitating removal of the anchor from the lacrimalduct.

The latch retracting means for retracting the latch 66, comprises aninner plunger 55 mounted for axial movement inside plunger 54 and havinga lower end that engages the top of a pusher or push pin 70 mounted foraxial movement inside plug 34, when the tool is engaged to the plug head40. By pushing down on a second button 57 connected to the inner plunger55, push pin 70 will push down on a spring 72 connected on the innerside of each latch 66, to pull the latch 66 radially inwardly, so itwill clear latch seat 68 and allow the plug to be disconnected form theanchor. Since no rotational motion of the plug is needed, the body 51 ofthe tool 50 may be cylindrical rather than hexagonal and the toolengaging recess 43 is conical. Otherwise the tool end is expandableradially outwardly to engage the enlarged base of the tool engagingrecess 43 by pushing down on button 56, as in the embodiment of FIG. 2.

The lower end of the push pin 70 will also transmit axial movement to asecond spring 74, e.g. a V-shaped spring connecting the projections 47in anchor 32, to pull the projections radially inwardly to disengagethem from the walls of the lacrimal duct to allow the anchor to bepulled from the duct using the tool when the punctal plug arrangement isto be removed from the patient.

Medicament sacks 80 and 82 are also schematically shown FIG. 4, asexamples of where and how medicaments can be charged into the punctalplug of the invention. The material of the anchor can be semipermeableto allow the medicine to be dosed to the patient, or one or more smallchannels can be provided in the anchor for this purpose, or anotherknown manner of dosing the patient can be used.

As shown in FIG. 5, the multi-part punctal plug arrangement can build onthe basic premise of the invention to provide more than two parts thatcan each be used for a different medicament in a single lacrimal duct.To this end the arrangement includes the anchor 32, the plug 34 and atleast one, but two, three or even more, intermediate punctal sections90, having an inner plug engaging recess 92 for receiving the stem 38 ofplug 34, and an outer surface for engaging a wall of a lacrimal duct,the intermediate section 90 also having a stem 94 for extending into theplug engaging recess 36 of the anchor 32 so that the intermediatepunctal section can be detachably and axially secured between the plug34 and the anchor 32.

While specific embodiments of the invention have been shown anddescribed in detail to illustrate the application of the principles ofthe invention, it will be understood that the invention may be embodiedotherwise without departing from such principles.

1. A punctal plug arrangement comprising three separable parts forplacement of an anchor and a plug in a lacrimal duct of a patient, thearrangement comprising: an anchor having an inner plug engaging recessand an outer surface for engaging a wall of a lacrimal duct forreceiving the anchor; a plug having a stem for extending into and forremovably engaging with the plug engaging recess of the anchor, and ahead connected to the stem, the head having a larger diameter than thestem for engaging around a lacrimal punctum at an end of a lacrimal ductin which the anchor is received, the head including a tool engagingrecess; wherein the plug engaging recess and the tool engaging recessare different recesses, and wherein said two recesses each comprise partof different physically separable components; an anchor fixing means atthe outer surface of the anchor for fixing the anchor to the wall of alacrimal duct for receiving the anchor; a plug fixing means fordetachably and axially securely connecting the plug to the anchor sothat with the plug connected to the anchor the plug and the anchor canbe inserted as a unit into, and removed as a unit from, a lacrimal ductfor receiving the anchor; and a tool having an end for removablyengaging the tool engaging recess of the plug, the end of the tool andthe tool engaging recess being adapted for axial securement of the toolto the plug so that the tool end can be used to selectably applyrotational, axial pushing, or axial pulling pressure on the plug;wherein the tool end and the tool engagement recess are adapted tofacilitate insertion and removal of the plug and connected anchor intoand out from a lacrimal duct for receiving the anchor; wherein thepunctal plug arrangement is adapted so that, with the end of the toolengaged to the tool engagement recess, the tool may be used to detachthe plug from the anchor, and also to apply axial pulling pressure tothe plug, and thereby to remove the plug from a position engaged arounda lacrimal punctum at the end of a lacrimal duct for receiving theanchor without also removing the anchor from a position within said samelacrimal duct.
 2. The punctal plug arrangement according to claim 1,wherein the plug fixing means comprises the stem of the plug and theinner plug engaging recess of the anchor being threaded so that the plugcan be rotated using the tool to be detachably and axially secured tothe anchor.
 3. The punctal plug arrangement according to claim 1,wherein the anchor fixing means comprises a plurality of fixedprojections on the outer surface of the anchor for engaging the wall ofa lacrimal duct.
 4. The punctal plug arrangement according to claim 1,wherein the end of the tool is radially expandable.
 5. The punctal plugarrangement according to claim 1, further including tool fixing meansfor detachably and axially securely connecting the tool to the plug,wherein the tool fixing means is capable of communicating axial pullingpressure from the tool to the plug.
 6. The punctal plug arrangementaccording to claim 1, including tool fixing means for detachably andaxially securely connecting the tool to the plug, the tool fixing meansincluding the tool having an expandable end, and the tool engagingrecess having an enlarged base for receiving the expanded end of thetool, to axially secure the tool end to the plug.
 7. The punctal plugarrangement according to claim 1, wherein the anchor fixing meanscomprise a plurality of projections on the outer surface of the anchorfor engaging the wall of a lacrimal duct, the projections being radiallymovable and the tool including means for radially retracting theprojections for facilitating removal of the anchor from the lacrimalduct.
 8. The punctal plug arrangement according to claim 1, wherein theplug stem comprises at least one radially movable latch; furthercomprising a latch seat in the plug engaging recess of the anchor fordetachably and axially securing the plug to the anchor by engagementwith the movable latch; wherein the tool comprises latch retractingmeans for retracting the latch radially to disengage the latch from thelatch seat and disconnect the plug from the anchor; and wherein the tooland the retractable latch are separable objects, and wherein the toolcan be selectably removed from the punctal plug arrangement.
 9. Thepunctal plug arrangement according to claim 1, further comprising amedicament in at least one of the plug and the anchor.
 10. The punctalplug arrangement according to claim 1, wherein the plug and the anchorare adapted for insertion into the punctum as solid objects; and whereinat least one of the plug and the anchor are at least partlyradio-opaque.
 11. The punctal plug arrangement according to claim 1,wherein the tool is substantially cylindrical; wherein the tool end isradially expandable; wherein the tool end comprises a plurality ofprongs; wherein the tool comprises a bore throughout the length of thetool; wherein the bore tapers inwardly at the tool end; the tool furthercomprising a plunger shaped to fit within the bore and slidablypositioned inside the bore; wherein a lower end of the plunger stopsabove the tapered portion of the bore in a first condition; wherein theprongs lay in substantially the same plane as the outside surface of thetool in the first condition; wherein the plunger may be presseddownwardly within the bore, with respect to the tool body, to achieve asecond condition where the lower end of the plunger engages the taperedportion of the bore tool and causes the prongs to move radially outwardat the tool end; and wherein the plunger may be moved upwardly withinthe bore, with respect to the tool body, to restore the tool to thefirst condition.
 12. The punctal plug arrangement according to claim 11,further comprising a second plunger mounted for axial movement withinthe first plunger; wherein the plug stem comprises at least one radiallymovable latch; the punctal plug arrangement further comprising a latchseat in the plug engaging recess of the anchor for detachably andaxially securing the plug to the anchor by engagement with the movablelatch; wherein the second plunger is adapted to selectably pull themovable latch radially inward to disengage the latch from the latch seatand thereby disconnect the plug from the anchor; and wherein the tooland the retractable latch are separable objects.
 13. A punctal plugarrangement comprising three separable parts for placement of an anchorand a plug in a lacrimal duct of a patient, the arrangement comprising:an anchor having an outer surface for engaging a wall of a lacrimal ductfor receiving the anchor; a plug having a head, the head being adaptedfor engaging around a lacrimal punctum at an end of a lacrimal duct inwhich the anchor is received, the head including a tool engaging recess;an anchor fixing means at the outer surface of the anchor for fixing theanchor to the wall of a lacrimal duct for receiving the anchor; a plugfixing means for detachably and axially securely connecting the plug tothe anchor so that with the plug connected to the anchor the plug andthe anchor can be inserted as a unit into, and removed as a unit from, alacrimal duct for receiving the anchor; a tool having an end forremovably engaging the tool engaging recess of the plug, the end of thetool and the tool engaging recess being adapted for axial securement ofthe tool to the plug so that the tool end can be used to selectablyapply rotational, axial pushing, or axial pulling pressure on the plug;wherein the tool end and the tool engagement recess are adapted tofacilitate insertion and removal of the plug and connected anchor intoand out from a lacrimal duct for receiving the anchor; wherein thepunctal plug arrangement is adapted so that, with the end of the toolengaged to the tool engagement recess, the tool may be used to detachthe plug from the anchor, and also to apply axial pulling pressure tothe plug, and thereby to remove the plug from a position engaged arounda lacrimal punctum at the end of a lacrimal duct for receiving theanchor without also removing the anchor from a position within said samelacrimal duct.
 14. The punctal plug arrangement according to claim 13,wherein the anchor fixing means comprises a plurality of fixedprojections on the outer surface of the anchor for engaging the wall ofa lacrimal duct.
 15. The punctal plug arrangement according to claim 13,wherein the end of the tool is radially expandable.
 16. The punctal plugarrangement according to claim 13, further including tool fixing meansfor detachably and axially securely connecting the tool to the plug,said tool fixing means being capable of transferring axial pullingpressure from the tool to the plug.
 17. The punctal plug arrangementaccording to claim 13, including tool fixing means for detachably andaxially securely connecting the tool to the plug, the tool fixing meansincluding the tool having an expandable end, and the tool engagingrecess having an enlarged base for receiving the expanded end of thetool, to axially secure the tool end to the plug.
 18. The punctal plugarrangement according to claim 13, wherein an anchor fixing meanscomprises a plurality of projections on the outer surface of the anchorfor engaging the wall of a lacrimal duct, the projections being radiallymovable and the tool including means for radially retracting theprojections for facilitating removal of the anchor from the lacrimalduct.
 19. The punctal plug arrangement according to claim 13, whereinthe plug stem comprises at least one radially movable latch; a latchseat in the plug engaging recess of the anchor for detachably andaxially securing the plug to the anchor by engagement with the movablelatch; wherein the tool comprises latch retracting means for retractingthe latch radially to disengage the latch from the latch seat anddisconnect the plug from the anchor; and wherein the tool and theretractable latch are separable objects, and wherein the tool can beselectably removed from the punctal plug arrangement.
 20. The punctalplug arrangement according to claim 13, further comprising a medicamentin at least one of the plug and the anchor.
 21. The punctal plugarrangement according to claim 13, wherein the plug and the anchor areadapted for insertion into the punctum as solid objects; and wherein atleast one of the plug and the anchor are at least partly radio-opaque.